After reading about ACTEMRA, please talk to your healthcare provider if you have any questions.

What is ACTEMRA?

ACTEMRA is a prescription medicine that targets the interleukin-6 (IL-6) signaling pathway.

ACTEMRA is used to treat:

Adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a Disease Modifying Anti-Rheumatic Drug (DMARD) has been used and did not work well

Adults with giant cell arteritis (GCA)

People with active PJIA ages 2 and above

People with active SJIA ages 2 and above

It is not known if ACTEMRA is safe and effective in children with PJIA or SJIA under 2 years of age or in children with conditions other than PJIA or SJIA.

ACTEMRA can cause serious side effects

ACTEMRA changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting ACTEMRA.

Before taking ACTEMRA, tell your healthcare provider if you have:

An infection, think you may have an infection, are being treated for an infection, or get a lot of infections that return. Infection signs, with or without a fever, include sweating or chills; shortness of breath; warm, red or painful skin or sores on your body; feeling very tired; muscle aches; blood in phlegm; diarrhea or stomach pain; cough; weight loss; burning when you urinate or urinating more often than normal

Any of the following conditions that may give you a higher chance of getting infections. These include diabetes, HIV, or a weak immune system

Tuberculosis (TB) or have been in close contact with someone who has TB. Your healthcare provider should test you for TB before starting ACTEMRA and during treatment with ACTEMRA

Lived in or currently live in parts of the United States known for fungal infections. These parts include the Ohio and Mississippi River Valleys and the Southwest

Hepatitis B or have had hepatitis B

Be sure to contact your healthcare provider or nurse if you see any signs of these side effects.

Stomach tears

If you have diverticulitis (inflammation in parts of the large intestine), talk to your healthcare provider before taking ACTEMRA.

Some people taking ACTEMRA may develop a hole in the wall of their stomach or intestines (also known as a perforation). This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.

Tell your healthcare provider right away if you see any of these side effects: fever, stomach-area pain that does not go away, or if you see a change in your bowel habits.

Changes in blood test results

Your healthcare provider should do blood tests before you start receiving ACTEMRA. If you have rheumatoid arthritis (RA) or giant cell arteritis (GCA) your healthcare provider should do blood tests 4 to 8 weeks after you start receiving ACTEMRA and then every 3 months after that. If you have polyarticular juvenile idiopathic arthritis (PJIA) you will have blood tests done every 4 to 8 weeks during treatment. If you have systemic juvenile idiopathic arthritis (SJIA) you will have blood tests done every 2 to 4 weeks during treatment. These blood tests are to check for the following side effects of ACTEMRA:

low platelet count. Platelets are blood cells that help with clotting, which stops bleeding

increase in liver function test levels

increase in blood cholesterol levels. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start receiving ACTEMRA, and then every 6 months after that

You should not receive ACTEMRA if your neutrophil and platelet counts are too low or your liver function test levels are too high. Your healthcare provider may stop your ACTEMRA treatment for a period of time or change your dose of medicine if needed because of changes in these blood test results.

Increased risk of cancer

ACTEMRA may increase your risk of certain cancers by changing the way your immune system works.

Hepatitis B infection

If you have hepatitis B, a virus that affects the liver, or are a carrier of the virus, ACTEMRA can cause the virus to become active. Your healthcare provider should test you for hepatitis B before starting treatment. Tell your healthcare provider right away if you see any signs of these symptoms: feeling very tired, vomiting, chills, dark urine, skin or eyes look yellow, clay-colored bowel movements, stomach discomfort, skin rash, little or no appetite, fevers, or muscle aches.

Serious allergic reactions

Serious allergic reactions, including death, can happen with ACTEMRA infusions or injections, even if they did not occur with an earlier infusion or injection. If you had hives, a rash, or experienced flushing after injecting, you should tell your healthcare provider or nurse before your next injection.

Contact 911 immediately, as well as your healthcare provider or nurse, if you experience any of these reactions: shortness of breath or trouble breathing; swelling of the lips, tongue or face; chest pain; feeling dizzy or faint; moderate or severe abdominal pain or vomiting.

Nervous system problems

While rare, multiple sclerosis has been diagnosed in some people taking ACTEMRA.

Most common side effects

Tell your healthcare provider if you have these or any other side effect that bothers you or does not go away: upper respiratory tract infections (like common cold and sinus infections), headache, increased blood pressure (also called hypertension), and injection site reactions.

ACTEMRA & pregnancy

Tell your healthcare provider if you are planning to become pregnant, are pregnant, plan to breast-feed, or are breast-feeding. You and your healthcare provider should decide if you will take ACTEMRA or breast-feed. You should not do both. If you are pregnant and taking ACTEMRA, join the pregnancy registry. The purpose of this registry is to check the health of the pregnant mother and her baby. To learn more, call 1-877-311-8972 or talk to your healthcare provider to register.

Reporting side effects

Tell your healthcare provider right away if you are experiencing any side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also call Genentech at 1-888-835-2555.

Help paying for ACTEMRA

Genentech Rheumatology Access Solutions® works with you
and your healthcare team to help you pay for ACTEMRA. Our programs can
help connect underinsured patients and patients on Medicare with
financial assistance foundations.

Please answer a few questions below to find out what you may be
eligible for or call us at 866-422-2377.

*In order to be eligible for the ACTEMRA Co-pay Card Program, the patient must have commercial insurance, must not have Medicare, Medicaid or other government insurance, and must meet other eligibility criteria. They also must agree to the rules set forth in the terms and conditions for the program. Please visit RACopay.com for the full list of terms and conditions.

You Might Qualify for a Referral to an Independent Co-pay Assistance Foundation

If you need help with your co-pay for your Genentech medicine, we can refer you to an independent co-pay assistance foundation.*

Note: If you were prescribed ACTEMRA Subcutaneous (SC) and have a Medicare Advantage or Medicare Part D plan, you may qualify for financial assistance with your Medicare prescription drug costs through the Low-Income Subsidy (LIS), also known as Extra Help. Learn more or apply for Extra Help from Medicare at https://secure.ssa.gov/i1020/start.

*Independent co-pay assistance foundations have their own rules for eligibility. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. We do not endorse or show financial preference for any particular foundation. The foundations we refer you to are not the only ones that might be able to help you.

You Might Qualify for a Referral to the Genentech Patient Foundation

The Genentech Patient Foundation provides free Genentech medicine to people who don't have insurance coverage or who have financial concerns and to people who meet certain income criteria.*

*If you have health insurance coverage for your medicine, you must have already tried other types of patient assistance to qualify for free Genentech medicine from the Genentech Patient Foundation. This includes the ACTEMRA Co-pay Card Program and support from independent co-pay assistance foundations. You must also meet financial criteria. If you do not have insurance or your insurance does not cover your medicine, you must meet different financial criteria.

ACTEMRA Co-pay Card Program Terms and Conditions

By using the ACTEMRA Co-pay Card Program, the patient acknowledges
and confirms that, at the time of usage, (s)he is currently eligible
and meets the criteria set forth in the terms and conditions described.

This Co-pay Card is valid ONLY for patients with commercial (private
or non-governmental) insurance who are taking the medication for a
Food and Drug Administration (FDA)-approved indication. Patients using
Medicare, Medicaid, or any other government-funded program to pay for
their medications are not eligible. Patients who start utilizing their
government coverage during their enrollment period will no longer be
eligible for the program.

This Co-pay Card Program is not health insurance or a benefit plan.
Distribution or use of the Co-pay Card does not obligate use or
continuing use of any specific product or provider. Patient or
guardian is responsible for reporting the receipt of all Co-pay Card
Program benefits or reimbursement received to any insurer, health
plan, or other third party who pays for or reimburses any part of the
prescription filled using the Co-pay Card Program, as may be required.

The Co-pay Card is not valid for medications the patient receives
for free or that are eligible to be reimbursed by private insurance
plans or other healthcare or pharmaceutical assistance programs (such
as Genentech® Access to Care Foundation (GATCF) or any
other charitable organization) that reimburse the patient in part or
for the entire cost of his/her Genentech medication. Patient,
guardian, pharmacist, prescriber, and any other person using the
Co-pay Card agree not to seek reimbursement for all or any part of the
benefit received by the recipient through the offer.

The Co-pay Card will be accepted by participating pharmacies,
physician offices, or hospitals. To qualify for the benefits of this
Co-pay Card Program, the patient may be required to pay out-of-pocket
expenses for each treatment. Once enrolled, this Co-pay Card Program
will not honor claims with date of service or medication dispensing
that precede program enrollment by more than 120 days. This Co-pay
Card is only available with a valid prescription and cannot be
combined with any other rebate/coupon, free trial, or similar offer
for the specified prescription. Use of this Co-pay Card must be
consistent with all relevant health insurance requirements and payer
agreements. Participating patients, pharmacies, physician offices, and
hospitals are obligated to inform third-party payers about the use of
the Co-pay Card as provided for under the applicable insurance or as
otherwise required by contract or law. The Co-pay Card may not be
sold, purchased, traded, or offered for sale, purchase, or trade. The
Co-pay Card is limited to 1 per person during this offer period and is
not transferable. Program eligibility period is contingent upon
patient’s ability to meet and maintain all requirements as set forth
by the program. Genentech will periodically verify eligibility and
will terminate patients without obligation to pay claims if change to
status is detected. This program is not valid where prohibited by law,
and shall follow state restrictions in relation to AB-rated generic
equivalents where applicable (eg, MA, CA).

The patient or their guardian must be 18 years or older to receive
Co-pay Card Program assistance. This Co-pay Card Program is (1) void
if the card is reproduced; (2) void where prohibited by law; (3) only
valid in the United States and Puerto Rico; and (4) only valid for
Genentech products. Healthcare providers may not advertise or
otherwise use the program as a means of promoting their services or
Genentech’s products to patients. Genentech reserves the right to
rescind, revoke, or amend the program without notice at any time.

The Access Solutions logo is a registered
trademark of Genentech, Inc.

The ACTEMRA Prepaid MasterCard is issued by The
Bancorp Bank pursuant to license by MasterCard International
Incorporated. This card may not be used everywhere debit MasterCard
is accepted. No cash or ATM access. The Bancorp Bank; Member FDIC.

SAFETY FIRST

Before reading more, please see the Important Side Effect Information for ACTEMRA

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Important Side Effect Information

After reading about ACTEMRA, please talk to your healthcare provider if you have any questions.

ACTEMRA is:

Available by medical prescription only

For adults with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate, that did not provide enough relief

For adults with giant cell arteritis (GCA)

For people with active PJIA ages 2 and above

For people with active SJIA ages 2 and above

It is not known if ACTEMRA is safe and effective in children with PJIA or SJIA under 2 years of age or in children with conditions other than PJIA or SJIA.

ACTEMRA can cause serious side effects

Serious infections

ACTEMRA changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. Some people have died from these infections.

Before taking ACTEMRA, tell your healthcare provider if you have:

An infection, think you may have an infection, are being treated for an infection, or get a lot of infections that return. Infection signs, with or without a fever, include:

Sweating or chills

Shortness of breath

Warm, red or painful skin or sores on your body

Feel very tired

Muscle aches

Blood in phlegm

Diarrhea or stomach pain

Cough

Weight loss

Burning when you urinate or urinating more often than normal

Any of the following conditions that may give you a higher chance of getting infections. These include: diabetes, HIV, or a weak immune system

Tuberculosis (TB) or have been in close contact with someone who has TB. Your healthcare provider should test you for TB before starting ACTEMRA and during treatment with ACTEMRA

Lived in or currently live in parts of the United States known for fungal infections. These parts include the Ohio and Mississippi River Valleys and the Southwest

Hepatitis B or have had hepatitis B

Be sure to contact your healthcare provider or nurse if you see any signs of these side effects.

Stomach tears

If you have diverticulitis (inflammation in parts of the large intestine), talk to your healthcare provider before taking ACTEMRA.

Some people taking ACTEMRA may develop a hole in the wall of their stomach or intestines (also known as a perforation). This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.

Tell your healthcare provider right away if you see any of these side effects:

Fever

Stomach-area pain that does not go away

Change in your bowel habits

Changes in blood test results

Your healthcare provider should do blood tests before you start receiving ACTEMRA. If you have rheumatoid arthritis (RA) or giant cell arteritis (GCA) your healthcare provider should do blood tests 4 to 8 weeks after you start receiving ACTEMRA and then every 3 months after that. If you have polyarticular juvenile idiopathic arthritis (PJIA) you will have blood tests done every 4 to 8 weeks during treatment. If you have systemic juvenile idiopathic arthritis (SJIA) you will have blood tests done every 2 to 4 weeks during treatment. These blood tests are to check for the following side effects of ACTEMRA:

You should not receive ACTEMRA if your neutrophil and platelet counts are too low or your liver function test levels are too high. These may cause your healthcare provider to stop your ACTEMRA treatment for a time or change your dose. Your cholesterol levels should be checked 4 to 8 weeks after the start of your treatment, and then every 6 months after that.

Increased risk of cancer

ACTEMRA may increase your risk of certain cancers by changing the way your immune system works.

Hepatitis B infection

If you have hepatitis B, a virus that affects the liver, or are a carrier of the virus, ACTEMRA can cause the virus to become active. Your healthcare provider should test you for hepatitis B before starting treatment. Tell your healthcare provider right away if you see any signs of these symptoms:

Feeling very tired

Vomiting

Chills

Dark urine

Skin or eyes look yellow

Clay-colored bowel movements

Stomach discomfort

Skin rash

Little or no appetite

Fevers

Muscle aches

Serious allergic reactions

Serious allergic reactions, including death, can happen with ACTEMRA infusions or injections, even if they did not occur with an earlier infusion or injection. If you had hives, a rash, or experienced flushing after injecting, you should tell your healthcare provider or nurse before your next injection.

Contact 911 immediately, as well as your healthcare provider or nurse, if you experience any of these reactions:

Shortness of breath or trouble breathing

Swelling of lips, tongue, or face

Chest pain

Feeling dizzy or faint

Moderate or severe abdominal pain or vomiting

Nervous system problems

While rare, multiple sclerosis has been diagnosed in some people taking ACTEMRA.

Most common side effects

Tell your healthcare provider if you have these or any other side effect that bothers you or does not go away:

ACTEMRA & pregnancy

Tell your healthcare provider if you are planning to become pregnant, are pregnant, plan to breast-feed, or are breast-feeding. You and your healthcare provider should decide if you will take ACTEMRA or breast-feed. You should not do both. If you are pregnant and taking ACTEMRA, join the pregnancy registry. The purpose of this registry is to check the health of the pregnant mother and her baby. To learn more, call 1-877-311-8972 or talk to your healthcare provider to register.

Reporting side effects

Tell your healthcare provider right away if you are experiencing any side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also call Genentech at 1-888-835-2555.

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